Surgical staple implant kit

ABSTRACT

An apparatus and a method are provided for a sterile staple implant kit that a surgeon may unpack and utilize during a surgery. The staple implant kit comprises a group of complementary surgery-specific instruments that are packaged in a sterile state. An instrument tray is configured to preserve the instruments in the sterile state until the staple implant kit is opened during the surgery. The instrument tray is configured to provide the surgeon with easy access to the instruments during the surgery. The staple implant kit comprises at least a staple inserter and a surgical staple suitable for being implanted in parallel holes drilled across a bone fusion or fixation site of a patient. The surgical staple preferably is loaded in a relaxed configuration into the staple inserter. A staple retention clip retains the surgical staple in the staple inserter until the staple is distracted during the surgery.

PRIORITY

This application claims the benefit of and priority to U.S. patentapplication Ser. No. 16/377,836 filed on Apr. 8, 2019 and U.S. patentapplication filed on Apr. 13, 2017 and having application Ser. No.15/487,305, now issued as U.S. Pat. No. 10,893,862 and U.S. Provisionalapplication, entitled “Surgical Staple Implant Kit,” filed on Apr. 13,2016 and having application Ser. No. 62/322,054.

FIELD

The field of the present disclosure generally relates to securing bonestogether. More particularly, the field of the disclosure relates to anapparatus and a method for a sterile staple implant kit that a surgeonmay unpack and utilize during bone fusion or fixation surgery.

BACKGROUND

Surgical staples or a fusion bone plate implant utilized in conjunctionwith one or more fasteners may be used to generate compression andstability at a bone interface. An implant generally serves to stabilizebones, or bone parts, relative to one another so as to promote bonefusion. In many applications, surgical staples, or bone plates andfasteners are used to fuse bones, or bone parts, of the human body, suchas bones in the foot, the ankle, the hand, the wrist, as well as variousother portions of the body. Surgical staples are particularlyadvantageous in the hands and feet due to a low dorsal profile of thestaples once they are implanted. Furthermore, during the course ofcertain medical procedures, a surgeon may immobilize one or more bonesor bone fragments by stabilizing the bones together in a configurationwhich approximates the natural anatomy. To this end, the surgeon may usefasteners to attach the bones to a bone plate implant so as to hold thebones in alignment with one another while they fuse together.

SUMMARY

An apparatus and a method are provided for a sterile staple implant kitthat a surgeon may unpack and utilize during a surgery. The stapleimplant kit is comprised of a group of complementary surgery-specificinstruments that are packaged in a sterile state. An instrument tray isconfigured to preserve the group of instruments in the sterile stateuntil the staple implant kit is opened during the surgery. Theinstrument tray is configured to provide the surgeon with easy access tothe group of instruments during the surgery. The staple implant kitcomprises at least a staple inserter and a surgical staple suitable forbeing implanted in parallel holes drilled across a bone fusion orfixation site of a patient. The surgical staple preferably is loaded ina relaxed configuration into the staple inserter. A staple retentionclip retains the surgical staple in the staple inserter until the stapleis distracted during the surgery. In some embodiments, the group ofinstruments may be further comprised of any of various surgical tools,such as, for example, drill sizers, forceps, staple removal tools,temporary pins, drill depth stops, fusion bone plates, bone platefasteners, compression screws, and the like.

In an exemplary embodiment, a sterile staple implant kit that a surgeonmay unpack and utilize during a surgery comprises a staple inserter anda surgical staple; a group of complementary surgery-specific instrumentsthat are packaged in a sterile state; and an instrument tray configuredto preserve the instruments in the sterile state and provide easy accessto the instruments during the surgery.

In another exemplary embodiment, the group of instruments comprises atleast the staple inserter and the surgical staple, the surgical staplebeing loaded into the staple inserter in a relaxed configuration of thesurgical staple. In another exemplary embodiment, the group ofinstruments comprises at least the staple inserter, the surgical staple,a bone drill, a drill guide, a locator pin, and a tamp. In anotherexemplary embodiment, the group of instruments further comprises any ofvarious surgical tools, such as drill sizers, forceps, staple removaltools, temporary pins, drill depth stops, fusion bone plates, bone platefasteners, compression screws, and the like.

In another exemplary embodiment, the staple inserter comprises a bodysupporting a distal force applicator that is mechanically coupled with aproximal handle, the distal forced applicator configured to distract thesurgical staple when the proximal handle is rotated in a clockwisedirection. In another exemplary embodiment, rotation of the proximalhandle moves a driver relative to a crown of the surgical staple, suchthat clockwise rotation of the proximal handle clasps the crown betweenthe driver and a pair of grips disposed within the distal forceapplicator, further clockwise rotation changing the surgical staple froma relaxed configuration to a distracted configuration suitable forimplantation across a bone fusion or fixation site of a patient. Inanother exemplary embodiment, the pair of grips comprises a first gripand a second grip, the first grip being disposed near a first leg of thesurgical staple, and the second grip being disposed near a second leg ofthe surgical staple, the first and second grips being configured toengage the crown on the same side of the surgical staple. In anotherexemplary embodiment, rotating the proximal handle counterclockwiseallows the surgical staple to relax from being distracted. In anotherexemplary embodiment, a staple retention clip is coupled with the distalforce application to retain the surgical staple in a relaxed stateduring sterilization, packaging, and shipping. In another exemplaryembodiment, the staple retention clip is configured to be removed fromthe distal force applicator during or after distracting the surgicalstaple prior to being implanted into a bone of a patient.

In another exemplary embodiment, the group of instruments includes adrill guide comprising a proximal handle and a pair of parallel sleevesconfigured to direct drilling of parallel holes across a bone fusion orfixation site of a patient, the positions of the parallel sleeves beingsubstantially similar to a distance between a first leg and second legof the surgical staple in a distracted configuration. In anotherexemplary embodiment, each of the parallel sleeves is configured toreceive and guide a bone drill configured for drilling holes in humanbone. In another exemplary embodiment, the group of instrumentscomprises a locator pin configured to be inserted through a first sleeveof the drill guide into a newly drilled hole in the bone of the patientduring drilling of a second hole in the bone by way of the second sleeveof the drill guide.

In an exemplary embodiment, a staple sizer for determining sizes ofsurgical staples during surgery comprises a disc-shaped membercomprising a plurality of sections corresponding to different sizes ofsurgical staples; a pair of parallel protrusions disposed within each ofthe plurality of sections and extending away from the center of thestaple sizer; and a pair of holes disposed adjacently to each pair ofparallel protrusions.

In another exemplary embodiment, the parallel protrusions are configuredto correspond to the positions of a first leg and a second leg of thesurgical staple in a distracted state of the surgical staple. In anotherexemplary embodiment, each of the plurality of sections comprises a sizeindicator configured to display a size of the surgical stable that, whendistracted, comprises first and second legs that substantially match thepositions of the parallel protrusions. In another exemplary embodiment,the pair of holes are configured to indicate a relationship betweenholes in bone suitably drilled across a bone fusion or fixation site ofa patient, the pair of holes corresponding to positions of a first legand a second leg of the surgical staple in a distracted state of thesurgical staple.

In an exemplary embodiment, a method for a sterile surgery-specific kitfor use during performing a surgery comprises assembling a group ofcomplementary instruments that are suitable for the surgery; sterilizingthe group of complementary instruments; configuring an instrument traysuitable to preserve the group of complementary instruments in a sterilestate, the instrument tray being configured to provide easy access tothe group of complementary instruments during the surgery; packaging thegroup of complementary instruments in the sterile state into theinstrument tray; and sealing the instrument tray to preserve the sterilestate until the surgery-specific kit is opened during the surgery.

In another exemplary embodiment, assembling comprises including at leasta staple inserter and a surgical staple in the group of complementaryinstruments, In another exemplary embodiment, assembling furthercomprises loading the surgical staple in a relaxed configuration intothe staple inserter, a staple retention clip being configured to retainthe surgical staple coupled with the staple inserter.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawings refer to embodiments of the present disclosure in which:

FIG. 1 illustrates a top plan view of an exemplary embodiment of asterile staple implant kit in accordance with the present disclosure;

FIG. 2A illustrates a rearward upper perspective view of an exemplaryembodiment of a staple inserter in accordance with the presentdisclosure;

FIG. 2B illustrates a forward upper perspective view of the exemplaryembodiment of the staple inserter illustrated in FIG. 2A, according tothe present disclosure;

FIG. 3A illustrates a rearward upper perspective view of an exemplaryembodiment of a staple inserter, according to the present disclosure;

FIG. 3B illustrates a forward upper perspective view of the exemplaryembodiment of the staple inserter illustrated in FIG. 3A, according tothe present disclosure;

FIG. 4 illustrates an upper perspective view of an exemplary embodimentof a bone drill guide, according to the present disclosure;

FIG. 5 illustrates a perspective view of an exemplary embodiment of atamp in accordance with the present disclosure;

FIG. 6 illustrates an upper perspective view of an exemplary embodimentof a bone drill and a locator pin in accordance with the presentdisclosure;

FIG. 7A illustrates a perspective view of an exemplary embodiment of astaple sizer, according to the present disclosure;

FIG. 7B illustrates a top plan view of the exemplary embodiment of thestaple sizer illustrated in FIG. 7A in accordance with the presentdisclosure;

FIG. 7C illustrates a side plan view of the exemplary embodiment of thestaple sizer illustrated in FIG. 7A in accordance with the presentdisclosure; and

FIG. 7D illustrates a perspective view of an exemplary embodiment of thestaple sizer illustrated in FIG. 7A. in accordance with the presentdisclosure.

While the present disclosure is subject to various modifications andalternative forms, specific embodiments thereof have been shown by wayof example in the drawings and will herein be described in detail. Theinvention should be understood to not be limited to the particular formsdisclosed, but on the contrary, the intention is to cover allmodifications, equivalents, and alternatives falling within the spiritand scope of the present disclosure.

DETAILED DESCRIPTION

In the following description, numerous specific details are set forth inorder to provide a thorough understanding of the present disclosure. Itwill be apparent, however, to one of ordinary skill in the art that theinvention disclosed herein may be practiced without these specificdetails. In other instances, specific numeric references such as “firstimplant,” may be made. However, the specific numeric reference shouldnot be interpreted as a literal sequential order but rather interpretedthat the “first implant” is different than a “second implant.” Thus, thespecific details set forth are merely exemplary. The specific detailsmay be varied from and still be contemplated to be within the spirit andscope of the present disclosure. The term “coupled” is defined asmeaning connected either directly to the component or indirectly to thecomponent through another component. Further, as used herein, the terms“about,” “approximately,” or “substantially” for any numerical values orranges indicate a suitable dimensional tolerance that allows the part orcollection of components to function for its intended purpose asdescribed herein.

In general, the present disclosure describes an apparatus and a methodfor a sterile staple implant kit that a surgeon may unpack and utilizeduring a surgery. The staple implant kit comprises a group ofcomplementary surgery-specific instruments that are packaged in asterile state. An instrument tray is configured to preserve theinstruments in the sterile state until the staple implant kit is openedduring the surgery. The instrument tray is configured to provide thesurgeon with easy access to the instruments during the surgery. Thestaple implant kit comprises at least a staple inserter and a surgicalstaple suitable for being implanted in parallel holes drilled across abone fusion or fixation site of a patient. In some embodiments, thestaple implant kit may further comprise a bone drill, a drill guide, alocator pin, and a tamp. The surgical staple preferably is loaded in arelaxed configuration into the staple inserter. A staple retention clipis configured to retain the surgical staple coupled with the stapleinserter until the staple is distracted during the surgery. A staplesizer is provided for determining sizes of surgical staples during thesurgery.

FIG. 1 illustrates an exemplary embodiment of a sterile staple implantkit 60, in accordance with the present disclosure. The sterile stapleimplant kit 60 comprises a group of complementary surgical instrumentsthat are sterilized and packaged together such that a surgeon may unpackand utilize the instruments during a bone fusion surgery. In theembodiment illustrated in FIG. 1, the instruments are supported in aninstrument tray 64 that is configured to preserve the instruments in asterile and undamaged state until the staple implant kit 60 is opened bythe surgeon during surgery. Further, the instrument tray 64 provides thesurgeon with easy access to the instruments during the surgery. In theembodiment of FIG. 1, the staple implant kit 60 comprises a drill guide68, a bone drill 72, a locator pin 76, a tamp 80, and a staple inserter100. In other embodiments, however, the staple implant kit 60 maycomprise other surgical tools and components, such as by way ofnon-limiting example, drill guides, drill sizers, tamps, forceps, stapleremoval tools, drills, temporary pins, drill depth stops, fusion boneplates, bone plate fasteners, compression screws, and the like.

FIGS. 2A and 2B illustrate perspective views of an exemplary embodimentof the staple inserter 100 in accordance with the present disclosure.The staple inserter 100 comprises a proximal handle 104, a body 108, anda distal force applicator 112. In the embodiment illustrated in FIGS.2A-2B, a surgical staple 116 is shown loaded within the distal forceapplicator 112, such that the surgical staple 116 is in a relaxedconfiguration suitable for packaging and shipping of the instrument 100before being distracted during implantation of the surgical staple 116at a bone fixation or fusion site of a patient. The surgical staple 116generally is of a variety indicated for fixation of osteotomies andjoint arthrodesis of the hands and feet. As such, the surgical staple116 preferably is comprised of a metal alloy exhibiting shape memory andsuperelastic properties, such as Nitinol or other similar material.Further, in some embodiments, multiple teeth suitable for engaging withbone may be disposed on one or more exterior surfaces of the surgicalstaple 116, such as, for example, along a backspan or crown of thestaple. In the embodiment illustrated herein, a multiplicity of teethare disposed along each of a pair of legs of the surgical staple 116 soas to discourage movement of the staple once implanted in bone. Itshould be understood, however, that the staple inserter 100 is not to belimited to distracting surgical staples, but rather may be used invarious other capacities, such as by way of non-limiting example,bending a bone fusion plate so as to tailor the plate to specificanatomy of a patient's bone being treated.

As best illustrated in FIGS. 3A-3B, the distal force applicator 112comprises a first grip 120, a second grip 124, and a driver (not shown)centered there between. The first and second grips 120, 124 areconfigured to cooperate so as to support a crown 132 of the surgicalstaple 116 when the driver is placed into forcible contact with thecenter of the crown 132. The forces on the crown 132 due to the driverand the grips 120, 124 operate to retain the surgical staple 116 withinthe distal force applicator 112, thereby facilitating implanting thestaple into the patient. As shown in FIG. 3A, the first and second grips120, 124 engage the surgical staple 116 on the same side of the crown132. A staple retention clip 128 prevents the crown 132 from becomingdislodged from the distal forced applicator 112 during packaging,sterilization, and shipping, as well as during distracting of thesurgical staple 116, as described herein.

Preferably, the first and second grips 120, 124 have a separationdistance comparable with the length of the crown 132. Thus, asillustrated in FIGS. 3A-3B, the first grip 120 is positioned near afirst leg 136 of the surgical staple 132, and the second grip 124 ispositioned near a second leg 140 of the staple. As will be appreciated,therefore, the distal force applicator 112 of the staple inserter 100 isconfigured to be used with specific sizes of surgical staples 116. Insome embodiments, the staple inserter 100 may be configured with anoverall size so as to be used with specific sizes of surgical staples116. In some embodiments, a color-matching system may be utilized toindicate to the surgeon that certain surgical staples 116 may beimplanted by way of the staple inserter 100. Further, in someembodiments, the first and second grips 120, 124 may have an adjustableseparation distance so as to facilitate using the staple inserter 100with a variety of differently-sized staples.

In the illustrated embodiment, the proximal handle 104 is mechanicallycoupled with the driver by way of a shaft that extends through the body108. At least a portion of the shaft may comprise a threaded portionthat rotatably engages with similar threads within a hole extendinglongitudinally through the body 108. In some embodiments, the driver maycomprise a distal extension of the shaft, having a narrower diameterthan proximal portions of the shaft. In some embodiments, the driver andthe shaft may be separate components that are engaged with one another.The shaft generally is fixedly coupled with the proximal handle 104 suchthat rotating the proximal handle 104 relative to the body 108 rotatesthe shaft within the body 108, and thus moves the driver longitudinallyrelative to the body and the crown 132. Further, the proximal handle 104may comprise a directional indicator 144 that indicates to the surgeondirections to rotate the proximal handle to distract and relax thesurgical staple 116. In the illustrated embodiment, rotating theproximal handle 104 clockwise, as viewed from the perspective of asurgeon operating the instrument 100, distracts the surgical staple 116,and rotating the proximal handle counterclockwise relaxes the surgicalstaple.

When the driver is not in contact with the crown 132, or the contact isminimal, the surgical staple 116 is in an initial, relaxed configurationwherein the first leg 136 and the second leg 140 of the staple bendtoward one another. The staple retention clip 128 serves to keep thecrown 132 fixedly engaged with the grips 120, 124, as shown in FIGS.2A-2B. As shown in FIG. 1, the staple inserter 100 preferably is storedin the staple implant kit 60 with the surgical staple 116 in the relaxedconfiguration and engaged with the grips 120, 124 by way of the stapleretention clip 128. Thus, the staple implant kit 60 removes the burden,on the surgeon, of locating and loading a suitably sized staple onto anappropriate bending instrument, thereby allowing the surgeon to focusattention on other important aspects of the surgery.

During operation of the staple inserter 100, twisting the proximalhandle 104 clockwise, as disclosed above, advances the shaft and movesthe driver distally toward the crown 132. Once the driver contacts thecenter of the crown 132, the surgical staple 116 becomes clasped betweenthe grips 120, 124 and the driver, at which point the staple retentionclip 128 may be removed from the distal force applicator 112. Furtherclockwise twisting of the proximal handle 104 exerts an increasingdegree of force onto the crown 132 by the grips 120, 124 and the driver.As will be appreciated, the distally-directed force due to the driverand proximally-directed forces due to the grips 120, 124 cause acorresponding distraction of the first and second legs 136, 140. Thus,clockwise twisting of the proximal handle 104 enables the surgeon tochange the surgical staple 116 from the initial, relaxed configuration,shown in FIGS. 2A-2B, to a distracted configuration wherein the firstand second legs 136, 140 are forced into a parallel relationshipsuitable for implanting the surgical staple 116 into a patient.

Once the surgical staple 116 is in the distracted configuration, and thestaple retention clip 128 has been removed, the surgeon may use thestaple inserter 100 to slide the first and second legs 136, 140 intoparallel holes drilled across a bone fusion or fixation site of thepatient. It will be appreciated that the forces exerted onto the crown132 by the grips 120, 124 and the driver maintain the distractedconfiguration of the surgical staple 116 during implantation. Thesurgeon may insert the first and second legs 136, 140 into the parallelholes until the first and second grips 120, 124 come into contact withthe patient's bone. The surgeon may then twist the proximal handle 104counterclockwise so as to retract the driver proximally away from thecrown 132, thereby allowing the surgical staple 116 to relax from thedistracted configuration. The shape memory and superelastic propertiesof the material comprising the surgical staple 116 ensure that thestaple advantageously compresses the bones to be fused as the stapleattempts to return to the initial configuration illustrated in FIGS.3A-3B. Once the driver has been suitably retracted from the crown 132,the surgeon may disengage the first and second grips 120, 124 from thecrown and then use the tamp 80 to push the legs 136, 140 into theparallel holes until the crown 132 is in direct contact with the bone.The surgeon may then close the incision by way of suturing.

As disclosed with respect to FIG. 1, the staple implant kit 60preferably comprises other surgical instruments that may assist thesurgeon with using the staple inserter 100 and the surgical staple 116.In the illustrated embodiment, the staple inserter 100 and the surgicalstaple 116 are accompanied by the drill guide 68, the bone drill 72, thelocator pin 76, and the tamp 80. In other embodiments, however,additional surgical instruments may be included in the staple implantkit 60, such as, by way of non-limiting example, drill sizers, forceps,staple removal tools, drill depth stops, fusion bone plates, bone platefasteners, compression screws, and the like.

FIG. 4 is a perspective view illustrating an exemplary embodiment of thedrill guide 68 that may be included in the staple implant kit 60,according to the present disclosure. The drill guide 68 is a generallyelongate member comprising a proximal handle 168 and a pair of parallelsleeves 172 configured to assist the surgeon with drilling osteotomyholes across a bone fusion or fixation site of a patient. An opening 176into each of the parallel sleeves 172 is configured to receive the bonedrill 72 and guide the drill into the interior of the sleeve. An angledportion 180 of the drill guide 68 is configured to facilitatesimultaneously grasping the proximal handle 168 and drilling theosteotomy holes by way of the parallel sleeves 172. Distal teeth 184disposed on the parallel sleeves 172 are configured to grip the bone ofthe patient and reduce movement of the drill guide 68 relative to thebone during drilling the osteotomy holes.

In the embodiment illustrated in FIG. 4, the drill guide 68 comprises asize indicator 188 disposed between the openings 176. The size indicator188 corresponds to the distance between the positions of osteotomy holesthat may be drilled by way of the drill guide 68. As will be recognized,the drill guide 68 aides the surgeon with preparing optimally positionedosteotomy holes for receiving the first and second legs 136, 140 in thedistracted state of the surgical staple 116. As such, the size indicator188 readily conveys to the surgeon the size of the surgical staple 116that may be inserted into osteotomy holes created with the drill guide68. It should be understood, however, that as members of the stapleimplant kit 60, illustrated in FIG. 1, the surgical staple 116 and drillguide 68 included in the kit preferably share complementary sizes. Thus,the drill guide 68 included in the staple implant kit 60 has a size thatadvantageously aides the surgeon with implanting the particular surgicalstaple 116 that is included in the kit. Further, in some embodiments,the size indicator 188 may include additional size-related information,such as information about the diameter of the sleeves 172, sizes ofcompatible drills, depth of the sleeves, and the like.

FIG. 5 is a perspective view illustrating an exemplary embodiment of thetamp 80 that may be included in the staple implant kit 60, in accordancewith the present disclosure. The tamp 80 is a generally elongate membercomprising a proximal handle 192 and a distal recess 196. As will berecognized, the tamp 80 advantageously enables the surgeon to push thelegs 136, 140 into parallel osteotomy holes until the crown 132 is indirect contact with the bone of the patient. To this end, the distalrecess 196 comprises a depth and a width configured to receivesubstantially an entirety of the crown 132. The proximal handle 192 isconfigured for grasping the tamp 80 during pushing of the crown 132 byway of the distal recess 196. In some embodiments, the tamp 80 mayinclude a size indicator configured to display one or more sizes of thesurgical staple 116 for which the tamp 80 is best suited.

FIG. 6 is a perspective view illustrating an exemplary embodiment of thebone drill 72 and locator pin 76 that may be included in the stapleimplant kit 60, according to the present disclosure. The bone drill 72is a generally elongate member configured for drilling holes in humanbone. The bone drill 72 comprises a proximal shank 200 configured to bereceived into a drill chuck. One or more flutes 204 angulate around acircumference of the drill and they extend to a distal cutting edge 208.As will be appreciated, the one or more flutes 204 are configured totransport bone cuttings away from the distal cutting edge 208 duringdrilling into bone. One or more depth annuli 212 may be disposedproximal to the flutes 204. Preferably, the depth annuli 212 may assistthe surgeon with drilling osteotomy holes to a desired depth.

The locator pin 76 generally comprises a small, symmetric shaftcomprising rounded ends 216 and a diameter suitable to be received intothe sleeves 172 of the drill guide 68. It is envisioned that the locatorpin 76 and the bone drill 72 may be used in conjunction with the drillguide 68 to drill parallel osteotomy holes across a bone fusion orfixation site of a patient. For example, during a bone fusion surgery,the surgeon may hold the drill guide 68 such that the sleeves 172 arecentered across the bone fusion or fixation site and then insert thebone drill 72 into a first of either of the sleeves 172 to drill a firstosteotomy hole into the bone of the patient. Upon removing the bonedrill 72, the surgeon may insert the locator pin 76 through the sleeve172 and into the newly drilled first osteotomy hole. With the locatorpin 76 positioned in the first sleeve 172 and the first osteotomy hole,the surgeon may insert the bone drill 72 into a second sleeve 172 anddrill a second osteotomy hole. It should be understood, therefore, thatthe locator pin 76, the bone drill 72, and the drill guide 68advantageously enable the surgeon to drill osteotomy holes that areoptimally positioned to receive the first and second legs 136, 140 inthe distracted state of the surgical staple 116, as disclosed herein.

As will be recognized, some surgical procedures may necessitate removinga surgical staple, such as the surgical staple 116, from a bone fusionor fixation site of a patent. It is envisioned that the surgeon may liftthe crown 132 away from the patient's bone surface by way of a suitableremoval tool so as to create enough clearance for the surgeon to engagethe grips 120, 124 between the bone and the crown 132. With the firstand second grips 120, 124 suitably engaged with the crown 132, thesurgeon may turn the proximal handle 104 clockwise to distally advancethe driver into contact with the center of the crown 132. Upon twistingthe proximal handle 104 so as to place the surgical staple 116 into thedistracted configuration, the surgeon may use the staple inserter 100 topull the first and second legs 136, 140 free of the patient's bone.

It should be understood that although the instruments comprising thestaple implant kit 60 have been discussed in combination with thesurgical staple 116, the staple implant kit 60 is not to be limited toimplanting surgical staples. Rather, the instruments comprising thestaple implant kit 60 may be used in various capacities other than asdescribed herein, such as, by way of non-limiting example, bending abone fusion plate so as to tailor the plate to a specific anatomy of apatient's bone being treated. Accordingly, the instruments comprisingthe staple implant kit 60 preferably are comprised of rigid materialssuitable for bending surgical implants, such as surgical staples andbone fusion plates, as described herein. In some embodiments, the rigidmaterials may be comprised of metal, plastic, or a combination of thetwo.

As disclosed above, the staple inserter 100 may be configured for usewith specific sizes of surgical staples 116. To this end, one or morestaple inserters 100 may be used in conjunction with a staple sizer 148,as shown in FIGS. 7A-7D. The staple sizer 148 is a generally disc-shapedmember comprising a plurality of sections 152 corresponding to differentsizes of surgical staples, such as the surgical staple 116. Each of theplurality of sections 152 comprises a pair of parallel protrusions 156extending away from the center of the stable sizer 148 and disposedadjacently to a pair of holes 160. The parallel protrusions 156correspond to the positions of the first and second legs 136, 140 in thedistracted state of the surgical staple 116. The pair of holes 160indicate the relationship between osteotomy holes suitably drilledacross a bone fusion or fixation site of the patient. Each section 152comprises a size indicator 164 that displays a size of the surgicalstable 116 that, when distracted, comprises first and second legs 136,140 that substantially match the positions of the parallel protrusions156. Further, the first and second legs 136, 140 of a distractedsurgical staple 116 may be inserted through the pair of holes 160 in anappropriate section 152 without effort.

As disclosed above, it is envisioned that the staple sizer 148 may beutilized during osteotomy to assist the surgeon in selecting anappropriately sized surgical staple 116. For example, after drillingosteotomy holes across a bone fixation site of the patient, the surgeonmay compare the osteotomy holes with the parallel protrusions 156 of thestaple sizer 148. Upon finding a pair of the parallel protrusions 156that best match the osteotomy holes, the surgeon may refer to the sizeindicator 164 to determine an appropriately sized surgical staple 116for implantation into the osteotomy holes of the patient. The surgeonmay compare the first and second legs 136, 140 of the distractedsurgical staple 116 with the holes 160 to verify the suitability of thestaple for implantation into the patient. As will be appreciated, thestaple sizer 148 effectively enables the surgeon to select anappropriately sized surgical staple 116, as well as the associatedstaple inserter 100, without being forced to unpack multiple unneededstaple implant kits 60 in an attempt to locate a desired size of thestaple.

While the invention has been described in terms of particular variationsand illustrative figures, those of ordinary skill in the art willrecognize that the invention is not limited to the variations or figuresdescribed. In addition, where methods and steps described above indicatecertain events occurring in certain order, those of ordinary skill inthe art will recognize that the ordering of certain steps may bemodified and that such modifications are in accordance with thevariations of the invention. Additionally, certain of the steps may beperformed concurrently in a parallel process when possible, as well asperformed sequentially as described above. To the extent there arevariations of the invention, which are within the spirit of thedisclosure or equivalent to the inventions found in the claims, it isthe intent that this patent will cover those variations as well.Therefore, the present disclosure is to be understood as not limited bythe specific embodiments described herein, but only by scope of theappended claims.

What is claimed is:
 1. A sterile staple implant kit that a surgeon mayunpack and utilize during a surgery, comprising: a staple inserter and asurgical staple; a group of complementary surgery-specific instrumentsthat are packaged in a sterile state; and an instrument tray configuredto preserve the instruments in the sterile state and provide easy accessto the instruments during the surgery.
 2. The sterile staple implant kitof claim 1, wherein the group of instruments comprises at least thestaple inserter and the surgical staple, the surgical staple beingloaded into the staple inserter in a relaxed configuration of thesurgical staple.
 3. The sterile staple implant kit of claim 2, whereinthe group of instruments comprises at least the staple inserter, thesurgical staple, a bone drill, a drill guide, a locator pin, and a tamp.4. The sterile staple implant kit of claim 3, wherein the group ofinstruments further comprises any of various surgical tools, such asdrill sizers, forceps, staple removal tools, temporary pins, drill depthstops, fusion bone plates, bone plate fasteners, compression screws, andthe like.
 5. The sterile staple implant kit of claim 1, wherein thestaple inserter comprises a body supporting a distal force applicatorthat is mechanically coupled with a proximal handle, the distal forcedapplicator configured to distract the surgical staple when the proximalhandle is rotated in a clockwise direction.
 6. The sterile stapleimplant kit of claim 5, wherein rotation of the proximal handle moves adriver relative to a crown of the surgical staple, such that clockwiserotation of the proximal handle clasps the crown between the driver anda pair of grips disposed within the distal force applicator, furtherclockwise rotation changing the surgical staple from a relaxedconfiguration to a distracted configuration suitable for implantationacross a bone fusion or fixation site of a patient.
 7. The sterilestaple implant kit of claim 6, wherein the pair of grips comprises afirst grip and a second grip, the first grip being disposed near a firstleg of the surgical staple, and the second grip being disposed near asecond leg of the surgical staple, the first and second grips beingconfigured to engage the crown on the same side of the surgical staple.8. The sterile staple implant kit of claim 5, wherein rotating theproximal handle counterclockwise allows the surgical staple to relaxfrom being distracted.
 9. The sterile staple implant kit of claim 5,wherein a staple retention clip is coupled with the distal forceapplication to retain the surgical staple in a relaxed state duringsterilization, packaging, and shipping.
 10. The sterile staple implantkit of claim 9, wherein the staple retention clip is configured to beremoved from the distal force applicator during or after distracting thesurgical staple prior to being implanted into a bone of a patient. 11.The sterile staple implant kit of claim 1, wherein the group ofinstruments includes a drill guide comprising a proximal handle and apair of parallel sleeves configured to direct drilling of parallel holesacross a bone fusion or fixation site of a patient, the positions of theparallel sleeves being substantially similar to a distance between afirst leg and second leg of the surgical staple in a distractedconfiguration.
 12. The sterile staple implant kit of claim 11, whereineach of the parallel sleeves is configured to receive and guide a bonedrill configured for drilling holes in human bone.
 13. The sterilestaple implant kit of claim 11, wherein the group of instrumentscomprises a locator pin configured to be inserted through a first sleeveof the drill guide into a newly drilled hole in the bone of the patientduring drilling of a second hole in the bone by way of the second sleeveof the drill guide.
 14. A staple sizer for determining sizes of surgicalstaples during surgery, comprising: a disc-shaped member comprising aplurality of sections corresponding to different sizes of surgicalstaples; a pair of parallel protrusions disposed within each of theplurality of sections and extending away from the center of the staplesizer; and a pair of holes disposed adjacently to each pair of parallelprotrusions.
 15. The staple sizer of claim 14, wherein the parallelprotrusions are configured to correspond to the positions of a first legand a second leg of the surgical staple in a distracted state of thesurgical staple.
 16. The staple sizer of claim 15, wherein each of theplurality of sections comprises a size indicator configured to display asize of the surgical stable that, when distracted, comprises first andsecond legs that substantially match the positions of the parallelprotrusions.
 17. The staple sizer of claim 14, wherein the pair of holesare configured to indicate a relationship between holes in bone suitablydrilled across a bone fusion or fixation site of a patient, the pair ofholes corresponding to positions of a first leg and a second leg of thesurgical staple in a distracted state of the surgical staple.
 18. Amethod for a sterile surgery-specific kit for use during performing asurgery, comprising: assembling a group of complementary instrumentsthat are suitable for the surgery; sterilizing the group ofcomplementary instruments; configuring an instrument tray suitable topreserve the group of complementary instruments in a sterile state, theinstrument tray being configured to provide easy access to the group ofcomplementary instruments during the surgery; packaging the group ofcomplementary instruments in the sterile state into the instrument tray;and sealing the instrument tray to preserve the sterile state until thesurgery-specific kit is opened during the surgery.
 19. The method ofclaim 18, wherein assembling comprises including at least a stapleinserter and a surgical staple in the group of complementaryinstruments,
 20. The method of claim 19, wherein assembling furthercomprises loading the surgical staple in a relaxed configuration intothe staple inserter, a staple retention clip being configured to retainthe surgical staple coupled with the staple inserter.